Bracket Community Events

On November 8th 2017, NAMI of PA Montgomery County hosted their 6th annual Benefit for the Brain event at the Philadelphia Marriott West in West Conshohocken, PA. The purpose of this fundraiser is to highlight the need for both medical and non-medical research and services for mental illness. The evening began at 6pm with an open cocktail hour, live music, silent auction, followed by a sit down dinner with the presentation of two awards: The Scientific Research Award and The Impact Award. Bracket sponsored this event and some of our team remembers attended the event.  By doing this together, we are able to raise funds to educate, support and advocate for those and their loved ones living with mental illness!

Bracket participated in the Walk Against Alzheimer’s in Philadelphia, PA on November 11, 2017. Not only did our team walk, but we also donated and raised over 7,000 dollars for this event. Raising over 300% of our goal has been an amazing accomplishment for the Bracket BrainStormers (team name). Most of us know or have lost someone to this terrible disease. Which is why Supporting the Alzheimer’s Association and the Walk to End Alzheimer’s is a long time passion of ours. Many of us here work on projects everyday that involve research on medications targeted at helping Alzheimer’s patients and their families cope with this awful disease. For some, the struggle is distant. Others have a grandparent, parent, aunt, uncle, or other relative or friend that had or is still living with this disease. Until these research efforts produce a cure, someone in the world develops dementia every 3 seconds. There were an estimated 46.8 million people worldwide living with dementia in 2015, and this number is believed to be close to 50 million people in 2017. This number will almost double every 20 years, reaching 75 million in 2030 and 131.5 million in 2050. We will keep supporting the Alzheimer’s Association and hope these efforts will help find a cure. Through our efforts, we were in 17th place out of 993 teams in fundraising. In addition, we also created the cutest pet contest to help benefit the Alzheimer’s Association. Frankie, pictured here, was our pet winner!

Bracket also participated in the Philabundance food drive this month – Camp out for Hunger. The food was raised by our Trevose office from 11 October to 21 November 2017, and was dropped off Monday, 27 of November. Radio hosts Preston and Steve from WMMR, broadcast live from Philadelphia during this event.  In addition, there were heated tents, carnival rides, and food was provided by local restaurants. Philly sports players, politicians and local celebrities stopped by to donate and meet fans.  Last year the COFH raised 1.36 million pounds of food. Each pound of food provides two meals. The food raised is collected by Philabundance and distributed at their locations and food banks all over the Philadelphia region. During the holiday season, everyone is reminded that we are lucky to never wonder where our next meal is coming from. As an office, we wanted to give back and help our neighbors in need in the Philadelphia region.

Bracket Strengthens Global Growth and Development Strategy with New Chief Commercial Officer, Christopher Crucitti

WAYNE, Pa., — Bracket, a leading clinical trial technology and specialty services provider, today announced the addition of Christopher Crucitti, Chief Commercial Officer to its global executive team. Crucitti joins Bracket as an experienced commercial leader in clinical and R&D services.

Crucitti brings industry-recognized experience, knowledge and integrity to Bracket’s leadership team as well as notable accomplishments in training and motivating other commercial professionals to provide a high level of customer service and overall performance. He will be responsible for the global commercial strategy and development of Bracket’s electronic clinical outcomes assessments (eCOA) and patient engagement platform, Randomization and Trial Supply Management (RTSM), Rater Training and Quality Assurance as well the Company’s expanding mobile suite for patient diary and analytics, among others.

“It’s with great excitement that we welcome Chris to our leadership team,” said Jeff Kinell, CEO at Bracket. “Chris brings an impressive resume in clinical commercial strategy to Bracket and has joined us at a pivotal time, as we continue to position ourselves competitively in the global marketplace through the increased use of Bring Your Own Device mobile solutions for patient engagement. We look forward to the unique and seasoned perspective Chris will bring to our team and global commercial strategy.”

Prior to joining Bracket, Crucitti served as Chief Commercial Officer at Science Exchange, a world-leading marketplace for outsourced research and as Executive Vice President, Global Business Development at Worldwide Clinical Trials, Inc., a global CRO that provides full-service drug development services to the pharma and biotech industries. Crucitti also held senior roles at InVentiv Health Clinical and i3 Research, a pharmaceutical services company that provides integrated solutions throughout the product lifecycle.

“I’m extremely excited to join Bracket, with its many smart and committed team members, leveraging my experience in clinical development services and technology to further optimize our commercial growth strategy,” said Crucitti, Chief Commercial Officer at Bracket. “With recent and imminent expansion on the horizon, the ability to communicate how our suite of technologies and solutions empower patient engagement to ultimately improve outcomes will be paramount; I look forward to the challenge and the many opportunities to expedite the process of getting meaningful treatments in the hands of patients that need them.”

Crucitti earned his Masters of Science in Health Management from American University and his Bachelors of Science in Cardiac Rehabilitation and Exercise Science from Ithaca College.

About Bracket
Bracket, with ten offices and more than 800 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Selecting the Parameters of a Dynamic Randomization

By Scott Hamilton, PhD

Most statisticians would agree that dynamic randomization results in superior treatment group balancing over list-based stratified permuted blocked randomization, thereby increasing the precision in a randomized clinical trial. There have been several studies and review articles that provide ample evidence in favor of dynamic randomization.

The motivation for this article was to dissipate the perceptions of complexity by elucidating the details of our process for choosing the randomization parameters. We also provide guidance for how we implement dynamic randomization for clinical trials in randomization and trial supply management (RTSM) systems.

At Bracket, our mission is to bring quality, resourcefulness, and dependability to the medicine development process. Improvements in the ability to implement sound and robust dynamic randomization systems provide us an easy landscape to utilize modern simulation techniques and graphical displays of quantitative data for making decisions about the biased‐coin probabilities and weights. Future discussions will explore more subtle and flexible methods to biased‐coin and weighting in dynamic randomization.

Read the full article from Applied Clinical Trials here

Bracket Breasties & Bracket BrainStormers

Bracket Breasties

Bracket participated in the Making Strides  Against Breast Cancer of Southeast PA, on Saturday, October 21st.  The Bracket Breasties support this event by donating, spreading awareness to all in their network, and walking. This year, we placed 9 out of 50 teams and raised way over our goal! Most people have unfortunately been touched by breast cancer in some way. By joining our local American Cancer Society, we can help make a difference and change lives for the better. We are proud to know that achieving our goal not only raises awareness, but will help enable investment in groundbreaking breast cancer research as well as provide free information and services for those diagnosed with the disease.

 

Bracket Brainstormers

On Saturday, November 11, the Bracket BrainStormers will Walk to End Alzheimer’s Disease in Philadelphia, PA. Supporting the Alzheimer’s Association and the Walk to End Alzheimer’s is a long time passion of ours. Many of us at Bracket work on projects every day that involve research on medications targeted at helping Alzheimer’s patients.  Currently, we are raising money for this cause and have exceeded our goal by 190%.  We cannot wait to walk this event. Stay tuned for pictures of the walk! If you are interested, please donate or walk this event here.

Bracket Acquires mProve Health to Radically Advance Patient Engagement in Clinical Trials

Wayne, Pa, — Bracket, a leading clinical trial technology and specialty services provider, today announced the strategic acquisition of mProve Health Inc. (mProve), a leading provider of mobile technologies for life science companies. The acquisition centers on both companies’ support of tech-enabled clinical trials that improve patient engagement through the use of “Bring Your Own Device” mobile tools in clinical trials.

Early-to-market with Electronic Clinical Outcomes Assessments (eCOA) and the first Randomization and Trial Supply Management (RTSM) mobile application, Bracket is at the forefront of digitization in clinical trials. Bracket helps biopharmaceutical sponsors and CROs increase the power of their data and identified a need to bring greater accuracy through technology. Included in mProve’s suite of regulatory compliant mHealth solutions is mPulse, an Electronic Patient-Reported Outcomes (ePRO) platform for enabling data collection via standalone native mobile apps or SMS text.  Other apps will enable communication with doctors and provide reminders and education.

In a recent report by KNect365, 94% of clinical trials professionals surveyed are looking to increase the utilization of mHealth, surpassing big data (86%) and cloud technology for EMRs (84%). These findings, among others, indicate mHealth technology as one of the most powerful opportunities in clinical trials. While mainstream eCOA providers are challenged to retrofit their systems to support emerging mHealth technologies and the BYOD movement, Bracket is now positioned for success with native mHealth capability.

“We are excited to announce the acquisition of mProve as we take a major step forward in our support of tech-enabled clinical trials,” said Jeff Kinell, CEO of Bracket. “As an early adopter of mHealth and BYOD, we recognize how these movements empower patients to become partners in their trials, and subsequently, deliver more accurate PRO and increase the likelihood of a successful trial.”

“This acquisition is an opportunity to bring the shared visions of mProve and Bracket into focus,” said Jeff Lee, CEO of mProve. “Both organizations center on improving patient engagement and driving adoption of the mHealth to do so. Together, we are well situated for a future of tech-enabled clinical trials.”

David Golde, Director at Genstar Capital, commented, “We are excited to be supporting Bracket’s first acquisition under Genstar ownership. Combined, Bracket and mProve’s solutions will deliver increased value to clinical trials through the greater use of technology. We look forward to working with Bracket management to continue pursuing strategic acquisitions that allow Bracket to better serve its customers.”

About mProve Health
mProve Health is a leading provider of mobile technologies for life science companies, helping them connect better with patients. The company offers industry-grade, regulatory compliant mobile solutions for patient recruitment, patient engagement, and electronic clinical outcome assessments (eCOA). mProve’s applications are used by 18 of the top 20 pharmaceutical companies, 15,000 clinical research sites in over 60 countries, and they are translated in over 50 languages to support patients across the globe. The company was founded in 2010 by Jeff Lee, CEO, an entrepreneur and mobile engagement strategist who founded three prior successful ventures, and Denis Curtin, PhD, CSO, a pharmacologist and pharmaceutical industry veteran. Learn more at www.mprove.com.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at www.bracketglobal.com.

About Genstar Capital
Genstar Capital (www.gencap.com) is a leading private equity firm that has been actively investing in high quality companies for more than 25 years. Based in San Francisco, Genstar works in partnership with its management teams and its network of strategic advisors to transform its portfolio companies into industry-leading businesses. Genstar manages funds with total capital commitments of approximately $9 billion and targets investments focused on targeted segments of the industrial technology, healthcare, financial services, and software industries.

Bracket Welcomes New Chief Technology Officer Sam Whitaker

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, today welcomed Sam Whitaker as Chief Technology Officer (CTO) to its growing team. Whitaker joins Bracket’s leadership team bringing ten years of experience in clinical technology and global infrastructure innovation to the Company.

Whitaker will be responsible for Bracket’s global product strategy, management and innovation, technology development and engineering including architecture, user experience (UX), user interface (UI) and IT support functions. Whitaker will leverage his ten years’ experience as co-founder and CEO of Greenphire, the first clinical technology to bring payment technology to the clinical environment.

During his tenure at Greenphire, Whitaker invented and successfully commercialized the first clinical trial payment technologies. The web-based applications were built on top of a global technology infrastructure, which he and his team designed to support the unique needs of sponsors, clinical research organizations (CROs) and sites and scaled to support more than 500 clients globally.

“Sam Whitaker joins Bracket with highly specific knowledge of clinical trial technology and a complete understanding of our technological vision,” said Jeff Kinell, CEO of Bracket. “As we continue to solidify our position as a global leader in clinical trial technology and specialty services, it’s imperative that we partner with our industry’s most innovative minds to lead and implement industry-wide advancements.”

Prior to Greenphire, Whitaker worked in the product division of Citigroup, designing technology solutions across verticals. He graduated from the University of Pennsylvania.

About Bracket

Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Expands Team with Industry Leader Dr. Amir Kalali

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, today introduced Amir Kalali, MD, as its Executive Advisor for Global Strategy . Dr. Kalali joins Bracket as a recognized leader in drug development methodology and technological innovation.

Dr. Kalali will work with Bracket’s leadership to help identify innovative technologies to support the evolution of its integrated growth. In addition, Dr. Kalali will assist in the acceleration of growth in Bracket’s CNS product lines in other fields of medicine.  He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications.

Previously, Dr. Kalali was Global  Head of the Neuroscience Center of Excellence at Quintiles IMS, where he was responsible for the enterprise-wide strategy for neuroscience, encompassing drug development and healthcare services.

Recognized globally as a leader in drug development and healthcare with an emphasis on  innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development  (ISCDD), a founding member of the International Society for CNS Clinical Trials and  Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and  previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures  frequently on drug development, innovation, technology, digital medicine and health.  He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business  at the University of California, Irvine.

“We are  thrilled  to welcome Dr. Kalali to Bracket,” said David G. Daniel, MD, Senior Vice President and Chief Medical Officer of Bracket. “Dr. Kalali’s depth and breadth of knowledge of clinical trial methodology and emerging technologies is unparalleled. We anticipate that Dr. Kalali will become a major contributor to Bracket’s  growth in eCOA, rater training and data quality monitoring solutions.” During his career, Dr. Kalali has been recognized five times by PharmaVOICE magazine as one of the 100 most inspiring leaders in life sciences. In 2014, he was awarded the PharmaVOICE Red Jacket Award in recognition of his career-long contributions to the industry.

Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

The Industry’s Need for an Advanced and Transformative IRT Solution

Byprimerano-jim Jim Primerano, Sr. Vice President and General Manager, eClinical at Bracket

Interactive Response Technology (IRT) is vital in managing the patients and drug supplies involved throughout all stages of clinical trial studies, but the most effective IRT systems offer more advanced functionality and seamless software integration. When these elements combine with innovations in user acceptance testing (UAT) and standardized delivery integration, the result is a next-generation IRT. This must-have technology streamlines automation processes to allow for rapid study deployment that integrates standardized delivery requirements, supports the majority of trial constructs and furthers the adoption of digitization in the life science industry.

Today, it exists in the form of the newly released Bracket CUBETM, an IRT solution that allows for streamlined, rapid trial deployment that increases the efficiency of clinical trials. When selecting an IRT to manage complex studies and connect clinical trial sites and supply chains, consider the core components and key benefits of this type of modern IRT solution.

  • A feature-rich configuration framework

An advanced IRT system is configured using an iterative UAT to lay the groundwork for a streamlined deployment process. Its capabilities allow sponsors to effortlessly leverage RTSM benefits without the associated constraints of time and cost. The model is easy to implement and aims for increased trial efficiency by deemphasizing requirement documentation and instead prioritizing unique configuration needs to enable superior statistical outcomes.

  • Rapid and streamlined study deployment

With this IRT solution, sponsors can deploy studies in one to two weeks through a UAT process that lets a study team fully visualize the RTSM system. This accelerates timelines and improves efficiency for all those involved, eliminating the need for pre-approved system requirement documentation. An advanced IRT supports most trial design constructs and focuses on a quick, user-accepted solution.

  • Collaborative user-centric configuration

A user acceptance build experience that welcomes engagement sets the new standard for the way sponsors collaborate to deploy IRT. With a rapid project lifecycle, this IRT lets sponsors experience the system prior to requirements approval. Its robust functionality supports an automated deployment process and makes it an easy to use, productive tool for clinical trial management.

Bracket has recently introduced CUBE, a transformative next-generation IRT solution for the life science industry, to its suite of configurable clinical research solutions. This new product leverages an iterative user acceptance build experience and Bracket’s full RTSM platform to streamline and accelerate study deployments. Possessing all the above qualities of a modern IRT system, CUBE is an advanced implementation model that balances cost and value creation for biotech and pharma sponsors.

For more information on interactive response technology and Bracket CUBE, click here.

Bracket Introduces Transformative IRT Solution, CUBE™, to Biotech and Pharma Sponsors

WAYNE, Pa — Bracket, a leading clinical trial technology and specialty services provider, announced today the release of CUBETM, a transformative interactive response technology (IRT) solution for the life sciences industry. Designed through an iterative user acceptance build experience, CUBE will be immediately available to qualifying biotechnology and pharmaceutical trial sponsors through Bracket.

The solution will enable biotech and pharma sponsors to utilize an innovative new solution to deploy studies in one to two weeks. It leverages an iterative user acceptance build experience to provide a rapid and advanced deployment methodology without the time and cost constraints of traditional IRT solutions. Key highlights of CUBE for biotech and pharma sponsors of any size include:

  • Accelerate times for sponsors and improves efficiency for CROs
  • Leverages Bracket’s full RTSM platform, but streamlines deployment through automation
  • Rapid project lifecycle lets sponsors experience the system prior to requirements approval
  • Reduce lengthy turnaround times for enhancements and in-study changes

“We’re so pleased to introduce CUBE to the life sciences marketplace and are confident that its easy-to-implement nature will improve the process of managing clinical supplies,” said Jeff Kinell, CEO at Bracket. “By deemphasizing requirement documents and prioritizing unique configuration needs, CUBE will undoubtedly evolve the paradigm of how sponsors collaborate to deploy IRT.”

The platform’s iterative UAT process allows study teams to visualize the RTSM system during the kick off meeting. This accelerates timelines for sponsors and improves efficiency for CROs. CUBE also leverages Bracket’s full RTSM platform, but streamlines the deployment of configuration profiles through automation. It’s intended to support most trial design constructs.

For more information, please visit www.bracketglobal.com/CUBE/.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Why Cloud Hosting can be the right choice for Clinical Trial Inventory Management Solutions

Byprimerano-jim Jim Primerano, Sr. Vice President and General Manager, eClinical at Bracket

As sites, sponsors and clinical research organizations (CROs) continue to manage more complex trial inventory, frequently on an international level, the need for an end-to-end clinical trial management solution that will ensure inventory is regulated in an FDA compliant manner is critical. Small to mid-sized companies often face challenges implementing these solutions, due to the complex IT infrastructure requirements, associated third-party costs and lack of in-house resources to maintain and manage the solution. These roadblocks highlight the advantages of a cloud-based solution, which is what Bracket is now offering for our SmartSupplies suite.

If you are considering upgrading from static Excel spreadsheets to intelligent inventory management software, consider how a cloud-based solution will benefit your organization almost immediately.

  • Saves money by reducing third-party management costs and overall IT footprint

In addition to being competitively priced and with reports demonstrating cloud-based services to reduce expenses by 50%, a solution hosted in the cloud will dramatically reduce third-party costs. Cloud hosting eliminates the need for hardware maintenance and management, thereby reducing the need for costly off-shore contractors and vendors. For companies without their own IT infrastructure and servers in place, a cloud-based solution eliminates the need to configure that framework – and instead, allows the company to focus on benefitting from the application itself.

  • Ensures compliance through proactive yet non-disruptive system health-checks

The transparency provided by cloud-hosted solutions allows your vendor to proactively monitor the software, push out updates and ensure all components are compliant with the latest FDA regulations. For example, your software provider can see if your organization is properly allocating memory space, if and when the infrastructure is aging and work to proactively mitigate the issues. Ultimately, the transparency of the cloud will allow your organization to focus first and foremost on running your clinical trial smoothly, rather than on incessant maintenance of your IT infrastructure.

  • Enables better collaboration across sites and easier integration with other eClinical systems

The smartest clinical trial inventory management software solutions are designed to facilitate end-to-end materials management for sponsors and enable greater collaboration. When hosted in the cloud, all involved parties – from clinical research associates to end-users – can seamlessly and instantaneously share data, regardless of geography. For clinical research associates who are running study management around the globe or for organizations who have thousands of end-users managing inventory at a site, it’s important to have easy and instant access to a shared database.

For more information on cloud-hosted inventory management solutions, click here.